GOVERNMENTAL ACTIVITIES

• Strengthening and streamlining of its regulatory system: amendment of the law on Pharmaceutical Affairs (PAL) to include a classification of the products according to their degree of risk, review of production surveillance standards, improvement of post-commercialisation product monitoring.
• 2005: Creation of the Pharmaceuticals and Medical Devices Agency (PMDA) to promote a transparent and more effective drug approval process.
• Strengthening of the requirements opposed to the pharmaceutical laboratories which must now be physically present on the national territory.
• In order to obtain the authorization for a new drug to be put on the market, pharmaceutical companies must demonstrate their ability to ensure the safety, quality and efficacy of the product, as well as their compliance with good manufacturing practices when producing products that are already on the market.
• Increased regulation and accountability of the laboratories.

USA 

• Multiplication of surveillance operations inside and outside the country targeted on the black market, online pharmacies and high risk imports.
• Obligation for the laboratories to update the information contained in the bar code (NDC) of each drug twice a year.
• Multiplication of the inspections of imported medicines’ production lines.
• In 2008, the State of Florida adopted an anti-counterfeiting Act hardening the penalties against repeat offenders and those who show no respect for human life or safety, notably by producing fake medicines.

Europe

Medicrime: The Council of Europe has established an international convention, which constitutes the first legally-binding instrument in the field of criminal law.
This convention criminalizes counterfeiting, but also the manufacturing and distribution of medical products that are put on the market without authorization or in violation of safety standards.

The Convention obliges the signatory States to define as criminal offences: 

• the manufacture of counterfeit medical products;
• the supply, the offer to supply and the trafficking of counterfeit medical products
• the falsification of documents;
• the non-authorised manufacture or supply of medical products and the commercialisation of medical devices that do not fulfil compliance requirements.
• Open to all countries of the world, “Médicrime” also offers a framework for international cooperation and measures to improve coordination at the national level.

This convention was adopted by the Committee of Ministers of the Council of Europe, on 8 December 2010, and its opening for signature is planned for October 28, 2011.
New 2011/62/EC directive: in May 2011 the Council of the European Union adopted a directive (Amendment of directive 2001/83/EC) aimed at preventing falsified drugs from being introduced into the legal supply chain.

The 2011/62/EC directive gives States 18 months to transpose the new rules into national law and in particular the following provisions: 

• Prescription drugs: Obligation to affix a safety device to verify the authenticity and identify each packaging throughout the supply chain, as well as to detect any trace of manipulation.
• Obligation to manufacture the active substances contained in the drugs, whether imported or not, according to good manufacturing practices.
• Obligation for all the importers, manufacturers and distributors of active substances to be registered with the competent authority.
• Obligation for manufacturers to inform the competent authorities when they suspect that drugs have been tampered with.
• Obligation for the member States to put in place systems for recalling falsified medicines.
• Obligation for internet sites offering drugs to display a common logo and include a link to the website of the relevant competent authority, on which should appear the list of all registered resellers.

France 

• October 2009: The French Presidency announced the reinforcement of the systems for detection and seizure in postal packages. Moreover, the national judicial Customs Service (SNDJ) saw its investigation and action capacity increased by the collaborative deployment of doctors and pharmacy inspectors.
• After the creation of specialized working groups in March 2011, the French Government put into operation in September 2011 a plan to fight against counterfeit health products in the country, most of which pass by the Internet.

This program covers four areas: operational cooperation between services, international action, statistical information and the training of public officials and magistrates.

The measures of this plan include:

• the creation of a central file of flights, diversions, or trafficking of pharmaceutical products;
• the constitution of mixed investigation teams and the implementation of inspections jointly carried out by police and customs officials;
• support for programmes aimed at strengthening the security of the channels of distribution of pharmaceutical products, in particular in developing countries;
• support for programmes aimed at strengthening the security of the channels of distribution of pharmaceutical products, in particular in developing countries;
• actions to increase awareness of consumers to the risks involved.
• the creation of a real program of training for all actors in the fight: administrative bodies and health professionals, as well as in schools, in Universities or in continuous training programmes.
• After the evaluation of Act No. 2007-1544 of October 29, 2007 concerning the fight against counterfeiting, the French Senate drafted a legislative proposal in July 2011 to strengthen the fight against counterfeiting. This proposal aims to provide details or clarifications and especially to further improve the protection of intellectual property in France.

Germany 

Blue Project:
The German customs have set up an original initiative based on the crossing of information from four different sources: internet, international organizations, pharmaceutical laboratories and online payment systems.
This international operation, conducted since 2008, specifically targets the commerce of counterfeit drugs via Internet.
The operation is based on the identification of illegal online drug-trading sites and the tracing of financial transactions. It can thus go back to the criminal organizations which are the source of the traffic.
The operation notably included tracing a major financial transaction (approximately 3 million Euros) through 7 different countries.

In April 2010, after 18 months of investigation, the operation gave rise to: 

• seven arrests,
• the seizure of over 172 000 drugs
• the seizure of € 390 000 in cash
• the confiscation of assets worth $700,000.

Great Britain

From 2007 to 2010, the regulatory authority of the country, the Medicines and Healthcare products Regulatory Agency (MHRA), led a plan to combat counterfeit drugs. This plan consisted of the following measures:

• Strengthening of the prerogatives of the Enforcement and Intelligence Group (E & I group) to investigate violations of the law on drugs.
• Hiring of specialists to conduct international and financial investigations, of criminologists, of Internet investigators …
• In-depth analyses of incidents
• Transparency of information and the strengthening of communication targeted to health professionals and the general public on the risks at stake in order to increase their vigilance.
• The creation of a 24 hour Hotline to report an incident.
• Strengthening of the consultation, collaboration and the exchange of information with police services (HMRC, SOCA…), international organizations (the WHO, Impact, Interpol, the Council of Europe…), professional federations of wholesalers (BAPW), of distributors (BAEPD), of the postal services (Royal Mail)…
• Publication of a list of the most frequently falsified medicines.
• …

Denmark 

• Strengthening of the inspections of manufacturers exporting to other countries of the European Community.

Russia 

• A law enacted in June 2007 allowed to arrest distributors and pharmacies involved in the sale of fake drugs.

India

• Intensification of the surveillance of areas of risk (borders, markets, rural zones…).
• Between 2003 and 2008, India substantially revised its health system.
• In 2008, the Government announced the creation of a fully autonomous Central Drug Authority (CDA) modelled on the American FDA.
• The Indian Government recognized the need for a more harsh regulation of the manufacturing  of drugs in India and has implemented a plan to improve laws and regulations.

China

• Hardening of sanctions against acts of corruption in the administration and the health authorities.
• More scrupulous respect and better control of the processing of applications for marketing authorizations. In 2007, the State Food and Drug Agency (SFDA) announced that the pharmaceutical companies had withdrawn more than 7300 requests for registration of drugs, amounting to about 24% of the total.
• Strengthening of the requirements to obtain the license to manufacture drugs.
• 2007: launch of a campaign of repression. More than 300 manufacturing plants of counterfeit medical devices and drugs were inspected by the authorities and closed.

Philippines 

• In 1996, the Republic of the Philippines adopted a specific law condemning drug counterfeiting. Sentences of imprisonment and fines are tiered according to the market value of the seized counterfeit goods, but also if it is found that one of the fake medicines has caused the death of someone.

Qatar: 

• Since June 2011, the Qatar is working on the creation of the first act to combat and criminalize the sale of forged drugs in the country. If passed, this Act should be the first of its kind in the Middle East.

Nigeria : 

Between 2001 and 2006: 

• Strengthening of the powers of the National Agency for Food and Drug Administration and Control  (NAFDAC)
• Prohibition of the import of drugs through terrestrial borders.
• Limitation of imports to two shipping ports and two airports.
• Prior declaration of the goods by the carrier to the NAFDAC
• Creation of the “West Africa Drug Regulatory Authority Network” (WADRAN), a forum of exchange for those responsible for the operations fighting against counterfeit drugs in the region.

Uganda :  

• Systematic batch by batch analysis, of all the medication destined to treat malaria and tuberculosis.